Actively Recruiting
Clinical Study of Regulatory T Cells (Tregs) in the Treatment of Neurodegenerative Diseases
Led by Novabio Therapeutics · Updated on 2025-09-25
12
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
Sponsors
N
Novabio Therapeutics
Lead Sponsor
T
The First Affiliated Hospital of Zhengzhou University
Collaborating Sponsor
AI-Summary
What this Trial Is About
An open, multi- center phase Ⅰ clinical study evaluating the safety and efficacy of autologous human polyclonal regulatory T cell injection (NP001 cell injection) in patients with Neurodegenerative diseases (ALS).
CONDITIONS
Official Title
Clinical Study of Regulatory T Cells (Tregs) in the Treatment of Neurodegenerative Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 70 years
- Diagnosed with sporadic or familial ALS according to Gold Coast Diagnostic Criteria and World Federation of Neurology El Escorial criteria
- Stable dose of riluzole and/or edaravone for more than one month before study entry
- More than two weeks since major surgery and completion of other research trials
- Recovered from clinical toxicity with toxicity values less than 2
- Serum creatinine less than or equal to 2.0 mg/dL
- AST and ALT less than 3 times the upper limit of normal
- Bilirubin less than 1.5 (except Gilbert's disease)
- Lung slow vital capacity over 70% of predicted normal
- No history of abnormal bleeding tendency
- Provided informed consent prior to study procedures
You will not qualify if you...
- Uncontrolled infection
- Hypertension not controlled by at least 3 drugs
- History of pulmonary embolism within 6 months before enrollment
- Significant heart conditions including recent myocardial infarction, severe heart failure, uncontrolled angina, severe arrhythmia, or abnormal ECG within 6 months
- History of coronary artery bypass grafting or angioplasty without cardiology evaluation
- Positive for HIV, hepatitis B, or hepatitis C
- Pregnant or lactating
- Unwillingness to use contraception if of childbearing potential
- Participation in other interventional studies
- Treatment with investigational drug, biologic, or device within 30 days or 5 half-lives before screening
- Prior ALS gene or cell therapy
- History of significant tumor, liver, kidney, or other uncontrolled diseases
- Presence of a feeding tube
- Current use of certain antipsychotics, antiepileptic drugs (except specified exceptions), or class 1 or 3 antiarrhythmic drugs
- At significant risk of suicide
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
Research Team
M
Mingqi Lu, MD., PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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